Well Done

The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two diabetes if the claims are not misleading and comply with other regulatory requirements.

FDA recently announced it does not object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease (CVD), provided that the qualified claim is appropriately worded so as not to mislead consumers.

Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified by US law, which are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. By law, those allergens must be listed separately from other ingredients on food labels. As discussed in a prior blog post, sesame is set to become the ninth major food allergen on January 1, 2023.

The US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on December 21, 2018, implementing the National Bioengineered Food Disclosure Standard (NBFDS). Beginning on January 1, 2022, the NBFDS will require manufacturers, importers, and retailers that package or sell food in bulk to disclose the presence of bioengineered food or food ingredients on product labels intended for retail sale.

Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve requirements related to summary nutrient information found on food labels.

The Federal Trade Commission (FTC) recently issued a final rule that marks a major shift in the regulatory landscape for labeling that has already begun to impact other regulatory bodies—namely, the US Department of Agriculture (USDA). The FTC’s new rule adds teeth to its longtime policy to prevent deceptive “Made in USA” (MUSA) claims, codifies its informal 1997 Enforcement Policy Statement on U.S. Origin Claims, and enables it to seek civil penalties of up to $43,280 for each violation of the rule.

US President Joseph Biden signed into law the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) in April, establishing sesame as the ninth major food allergen under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the first new major food allergen to join the list since its creation in 2004.

Harvard Law School’s Animal Law & Policy Clinic (Clinic) submitted a petition on June 9 to the USDA’s Food Safety and Inspection Service (FSIS), urging it to adopt a labeling approach for the emerging category of cell-based meat and poultry that “does not overly restrict speech and that respects the First Amendment."

The Mexican Ministry of Economy and Federal Commission for the Protection Against Sanitary Risks approved a project on January 24 to modify the mandatory “Official Mexican Standard NOM-051-SCFI/SSA1-2010, General Labeling Specifications for Pre-packaged, Non-alcoholic Foodstuffs and Beverages” (NOM-051).

FDA issued a final rule on October 28 that revises the type size requirement for front-of-pack (FOP) calorie labeling for food sold from glass-front vending machines. This new rule amends FDA’s 2014 final rule, which requires vending machine operators that own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines.